Trisodium trihydrogen 5,5',5''-(1,3,5-triazine-2,4,6-triyltriimino)tris[5-sulphonatosalicylate]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

well performed guideline study according to OECD 405

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium trihydrogen 5,5',5''-(1,3,5-triazine-2,4,6-triyltriimino)tris[5-sulphonatosalicylate]

EC Number:

279-091-6

EC Name:

Trisodium trihydrogen 5,5',5''-(1,3,5-triazine-2,4,6-triyltriimino)tris[5-sulphonatosalicylate]

Cas Number:

79135-90-3

Molecular formula:

C24H18N6O18S3.3Na

IUPAC Name:

trisodium 3-({4,6-bis[(3-carboxy-2-hydroxy-5-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)-5-carboxy-4-hydroxybenzene-1-sulfonate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Source: Kleintierfarm Madoerin AG, 4414 Fuellingsdorf, Switzerland
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.3 kg to 3.0 kg
- Housing: Individually in stainless steel cages equipped with an automatic drinking water supply and cleaning system
- Diet (e.g. ad libitum): standard rabbit maintenance feed Kliba 23/341/1, Klingentalmuehle AG ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° ± 2°C (air-condition)
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

One administration

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

Application of the substance to the conjunctival sac of the left eye of each animal, the right eye remained untreated and served as control respectively

REMOVAL OF TEST SUBSTANCE
- Washing: in 3 out of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with physiological saline for about one minute.

The eyes were examined and the grade of ocular reactions recorded at 1, 24, 48 and 72 hours after treatment and at 7, 14 and 21 days after treatment, unless the eye is normal at 72 hours, 7 or 14 days.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of six animals

Time point:

other: after 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not relevant since no effects occured

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of six animals

Time point:

other: after 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: reversibility not relevant since no effects occured

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of three animals (eyes not rinsed)

Time point:

other: after 24, 48 and 72 hours

Score:

0.22

Max. score:

4

Reversibility:

other: grade 1 chemosis was observed in all animals at 1 hour and was fully reversible after 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of tree animals (eyes rinsed)

Time point:

other: after 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: grade 1 chemosis was observed in 2 anmials at 1 hour and was fully reversible after 24 hours

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of three animals (eyes not rinsed)

Time point:

other: after 24, 48 and 72 hours

Score:

0.33

Max. score:

4

Reversibility:

other: grade 1 redness was observed in 2 animals at 1 hour and was fully reversible after 48 hours

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of three animals (eyes rinsed)

Time point:

other: after 24, 48 and 72 hours

Score:

0.1

Max. score:

4

Reversibility:

other: grade 1 redness was observed in 2 animals at 1 hour and was fully reversibel after 48 hours.

Irritant / corrosive response data:

No corrosion effect was observed at each of the measuring intervals.

Other effects:

no coloration of the cornea and conjunctivae was observed in the rabbits during the entire test period which could be related to compound effects.
No acute toxicological signs were observed in the animals during the test period.

Any other information on results incl. tables

individual results:

animal sex	treatment of eye	time	cornea opacity	iris	conjunctiva redness	conjunctiva chemosis
55 male	not rinsed	1 h	0	0	2	1
56 male	not rinsed		0	0	1	1
57 male	not rinsed		0	0	2	1
58 female	rinsed		0	0	0	0
59 female	rinsed		0	0	1	1
60 female	rinsed		0	0	1	1
55 male	not rinsed	24 h	0	0	1	1
56 male	not rinsed		0	0	1	0
57 male	not rinsed		0	0	1	1
58 female	rinsed		0	0	0	0
59 female	rinsed		0	0	1	0
60 female	rinsed		0	0	0	0
55 male	not rinsed	48 h	0	0	0	0
56 male	not rinsed		0	0	0	0
57 male	not rinsed		0	0	0	0
58 female	rinsed		0	0	0	0
59 female	rinsed		0	0	0	0
60 female	rinsed		0	0	0	0
55 male	not rinsed	72 h	0	0	0	0
56 male	not rinsed		0	0	0	0
57 male	not rinsed		0	0	0	0
58 female	rinsed		0	0	0	0
59 female	rinsed		0	0	0	0
60 female	rinsed		0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the findings in this study, the test item does not meet the criteria for classification according to Regulation (EC) No. 1272/2008.

Executive summary:

The primary eye irritation potential of the test item was investigated according to a OECD test guideline No. 405. 100 mg test item was inserted into the conjunctival sac of the left eye of 3 male and 3 female young adult New Zealand White rabbits respectively. In the female animals approximately 30 seconds after treatement the treated eyes were flushed with physiological saline for about one minute. The eyes of the male animals were not rinsed. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation. 

The mean score was calculated separately for each animal across three scoring times (24, 48 and 72 hours after instillation) for corneal opacity, iritis, redness and chemosis of the conjunctivae. The individual mean scores for corneal opacity and iritis was 0.0 for all animals. Mean scores for the conjunctivae were 0.33 for reddening and 0.22 for chemosis (males). The mean score for the females was 0.1 for conjunctiva reddening.

All observed effects were reversible within 48 hours. No corrosion was observed at any of the measuring intervals. No clinical signs of toxicity were observed.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye.

According to the findings in this study, the test item does not meet the criteria for classification according to Regulation (EC) No. 1272/2008.